JA_Redacted.pdf

Form 02.4G.AB 18 Apr 2016

JUSTIFICATION AND APPROVAL

OTHER THAN FULL AND OPEN COMPETITION

1. Identification of the agency and the contracting activity, and specific identification of the document as a

“Justification for other than full and open competition.”

This justification is executed by the Naval Medical Logistics Command (NMLC), Fort Detrick, MD, on behalf of the Navy to meet the requirements of Naval Hospital (NH) Jacksonville.

2. Nature and/or description of the action being approved.

The proposed action is to support and maintain designated, Government-owned Stryker endoscopes, operating room equipment, surgical systems, and instruments located at Naval Hospital (NH) Jacksonville. The Government intends on awarding a Firm, Fixed-Price (FFP) contract. The proposed source is Stryker Corporation, 5900 Optical Court, San Jose, CA 95138-1400.

3. A description of the supplies or services required to meet the agency’s needs (including the estimated value).

Naval Hospital (NH) Jacksonville has a requirement for a non-personal services contract to maintain designated, Government-owned endoscopes, operating room equipment, surgical systems, and instruments, manufactured by

Stryker Corporation and/or their subsidiary companies. Maintenance and support shall be provided for a one (1) year period of performance spanning 02 April 2018 through 01 April 2019, including four subsequent option years.

The selected vendor must be able to provide support immediately upon award of a resulting order.

The Contractor shall maintain all equipment listed in the performance work statement. The Contractor shall maintain the systems within the original equipment manufacturer’s (OEM) specifications, in accordance with all

U.S., State, and Local laws and regulations, U.S. Navy regulations, instructions, and Joint Commission requirements. The Joint Commission’s requirements are specified in its Comprehensive Accreditation Manual for

Hospitals (CAMH), readily found on https://www.jointcommission.org/. U.S. Navy regulations and instructions will be made available upon request. The Contractor must maintain any networkable systems such that they meet

Navy and DHA Cybersecurity requirements.

The firm, fixed-price (FFP) maintenance contract shall include unlimited telephone support (24 hours, 7 days a week), preventive maintenance and inspections, corrective maintenance tasks, and unlimited emergency responses by the Contractor’s Field Service Engineers for all medical devices listed in the performance work statement. All maintenance provisions shall apply to hardware, firmware, and software, as appropriate, unless otherwise stated.

The Contractor shall provide all parts, labor, materials, travel, personnel, supervision, and freight shipping for the scheduled, preventive, and corrective maintenance of all equipment identified.

When product recalls, updates, or upgrades are necessary to maintain the contractual equipment inventory within the

OEM’s specifications, the Contractor shall obtain and install same.

The aggregate amount of equipment covered under the contract shall fluctuate over time, as hardware and software eclipse useful life and as new equipment comes off warranty. However, the aggregate requirement and level of effort will remain relatively constant over the life of the contract. Any changes to the equipment list will be executed through an official contract modification.

This contract shall provide unscheduled support/service coverage between the hours of 0700 and 1700 (Eastern

Standard Time), Monday through Friday, excluding United States Federal Government holidays, which are identified online at the following site: https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay.

Vendor shall be an Original Equipment Manufacturer (OEM) authorized dealer, authorized distributor, or authorized reseller for the equipment/system, such that OEM warranty and service are provided and maintained by the OEM.

All software licensing, warranty, and service associated with the equipment/system shall be in accordance with the

OEM terms and conditions.

https://www.jointcommission.org/ https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay https://www.opm.gov/policy-data-oversight/pay-leave/pay-administration/fact-sheets/holidays-work-schedules-and-pay

4. An identification of the statutory authority permitting other than full and open competition.

The statutory exception permitting other than full and open competition for this acquisition is 10 U.S.C. 2304(c)(1) and FAR 13.106-1(b)(2), soliciting from a single source for purchases exceeding the simplified acquisition threshold.

5. A Demonstration that the proposed contractor’s unique qualifications or the nature of the acquisition requires use of the authority cited.

Only one vendor, Stryker Corporation (Stryker), can provide maintenance on this equipment that meets the requirement of the Government. Stryker is the only source that has proprietary root/administrative level access to their manufactured endoscopy and OR integration information systems. Necessary software updates and upgrades can only be patched or applied with Stryker’s assistance. Additionally, Stryker asserts that they do not certify third parties to maintain their equipment. Further, in instances where existing, Government-owned scopes are beyond

OEM repair, Stryker is the only vendor capable of providing replacement scopes of the exact same part/model number, generation, with new or like-new image quality. Therefore, Stryker is the only company that can provide the maintenance services required by the Government for the entirety of the designated equipment list.

6. A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable, including whether a notice was or will be publicized as required by Subpart 5.2 and, if not, which exception under 5.202 applies.

Market research was performed, the results of which are in paragraph 8. This requirement will be posted to

FedBizOpps in accordance with FAR 5.202.

7. A determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer shall determine the anticipated cost to the Government of the supplies/services covered by this Justification and Approval will be fair and reasonable by conducting a price analysis before an award is made.

In addition, the Government anticipates that the negotiated contract price will reflect a discount from the vendor’s commercial price list and will be determined fair and reasonable.

8. A description of the market research conducted (see Part 10) and the results, or a statement of the reason market survey was not conducted.

Market research was conducted by technical experts from August to October of 2017. This research consisted of reviews of similar previous maintenance procurements and a review of open market contractors and Federal Supply

Schedule contractors. Search engines utilized include Google, Bing, GSA Advantage, ECRI, FBO, and SAM.

The most common medical device parts providers, such as PartsSource and AlphaSource, were queried as a part of this market research. While PartsSource and AlphaSource both listed many component parts for Stryker booms, waste evacuation systems, and surgical lights, they did not indicate whether the parts were new, non-refurbished

OEM parts. Further, they did not offer any parts or software for Stryker endoscopic cameras or integration information systems.

In researching Stryker’s website and discussing service options with Stryker’s service contacts, it was discovered that only Stryker has root/administrative level access to their manufactured OR integration information systems.

In reviewing ECRI’s list of service companies, no third-parties or distributors are listed for Stryker

Communications, Endoscopy, or Instruments. For procurement of Stryker-branded equipment, Stryker does have a partnership with American Medical Depot (AMDNext). However, AMDNext does not employ any field service personnel and would simply defer all service back to Stryker Endoscopy, Communications, and Instruments. This does not meet the requirements of the Government.

Based on market research it has been determined that only Stryker can meet the minimum requirements of the

Government.

9. Any other facts supporting the use of other than full and open competition.

None.

10. A listing of the sources, if any, that expressed, in writing, an interest in the acquisition.

To date, no other sources have written to express an interest. Any sources expressing interest in response to the synopsis will receive consideration.

11. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before any subsequent acquisition for the supplies or services required.

Future requirements will be synopsized in accordance with FAR 5.203. For the reasons set forth in Paragraph 5, Naval Medical Logistics Command has no plans at this time to compete future contacts for the types of supplies/services covered by this document. If another potential source emerges, (NMLC) will assess whether competition for future requirements is feasible.